The Biosimilars Market

Biosimilars, or ‘follow-on biologics’ as they are known in the US, provide access to affordable and effective medicines to patients around the world. Although the regulatory pathway put forward by the European Medicines Agency (EMEA) has facilitated the launch of a number of biosimilars, the market is still considered to be in a nascent stage. Estimates from IMS Health suggest that products worth $25 billion are expected to go off-patent by 2017, creating a significant opportunity for biosimilar players.

This article aims to set out the key challenges facing biosimilar market participants, in addition to various factors driving and restraining market growth. It also provides an overview of the competitive landscape of the current biosimilars industry and market trends.

THE ROLE OF BIOSIMILARS IN CONTROLLING PHARMACEUTICAL EXPENDITURE

One of the biggest problems facing developed economies around the world is the increase in per capita healthcare spending, which surpasses per capita income in several cases. As Figure 1 indicates, this trend is unsustainable in the long-run, and most governments have begun to take measures to ensure that spending growth falls in line with per capita income. Pharmaceutical expenditure, which is a critical component of healthcare budgets across the world, is being widely recognised as an area that needs to be controlled. This is precisely where generics and biosimilars have a crucial role to play. According to the European Generic medicines Association (EGA), generic medicines have made major contributions to affordable and accessible healthcare for over 20 years, saving the EU an estimated €20 billion annually. by 2017, creating a significant opportunity for biosimilar players.